Philips Medical Systems

FDA Filings

This page includes the latest FDA filings for Philips Medical Systems. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Philips Medical Systems holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1937850
FEI Number1937850
NamePhilips Medical Systems
Owner & OperatorPhilips Medical Systems International BV
Contact AddressTussendiepen 4
Drachten NL-NOTA 9206 AD NL
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2039 Concourse Dr
Saint Louis, MO 63146 US
Establishment TypeManufacture Medical Device



FDA Owner/Operator Registration

























FDA Filings

Device
Company
DeviceDate
Philips Medical Systems
Paper 9898031368912021-11-18
Philips Medical Systems
HeartStart FRx Defibrillator (861304)2021-11-15
Philips Medical Systems
PageWriter 8604662021-10-15
Philips Medical Systems
989803172151 9898031721512021-10-01
Philips Medical Systems
989803172131 9898031721312021-10-01
Philips Medical Systems
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System2021-09-24
Philips Medical Systems
HeartStart FRx Defibrillator (861304)2021-09-24
Philips Medical Systems
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System2021-09-08
Philips Medical Systems
Microstream Advance Neonatal-Infant Nasal CO2 Filter Line 9898032046312021-08-02
Philips Medical Systems
Microstream Advance Adult Nasal CO2 Filter Line 9898032046212021-08-02
Philips Medical Systems
Microstream Advance Adult Nasal CO2 Filter Line 9898032046112021-08-02
Philips Medical Systems
Microstream Advance Pediatric Nasal CO2 Filter Line 9898032046012021-08-02
Philips Medical Systems
Microstream Advance Pediatric Nasal CO2 Filter Line 9898032045912021-08-02
Philips Medical Systems
Microstream Advance Adult Nasal CO2 Filter Line 9898032045812021-08-02
Philips Medical Systems
Microstream Advance Adult Oral-Nasal CO2 Filter Line 9898032045712021-08-02
Philips Medical Systems
Microstream Advance Pediatric Oral-Nasal CO2 Filter Line 9898032045612021-08-02
Philips Medical Systems
Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 9898032045112021-08-02
Philips Medical Systems
Microstream Advance Pediatric Nasal CO2 Filter Line 9898032045012021-08-02
Philips Medical Systems
Microstream Advance Adult Nasal CO2 Filter Line 9898032044912021-08-02
Philips Medical Systems
Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line 9898032044712021-08-02
Philips Medical Systems
Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line 9898032044512021-08-02
Philips Medical Systems
Microstream Advance Neonatal-Infant Nasal CO2 Filter Line 9898032044412021-08-02
Philips Medical Systems
Microstream Advance Neonatal-Infant Nasal CO2 Filter Line 9898032044312021-08-02
Philips Medical Systems
Microstream Advance Adult Oral-Nasal CO2 Filter Line 9898032043912021-08-02
Philips Medical Systems
Microstream Advance Adult Oral-Nasal CO2 Filter Line 9898032043712021-08-02
Philips Medical Systems
Microstream Advance Adult Oral-Nasal CO2 Filter Line 9898032043612021-08-02
Philips Medical Systems
Microstream Advance Pediatric Oral-Nasal CO2 Filter Line 9898032043512021-08-02
Philips Medical Systems
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 9898032043412021-08-02
Philips Medical Systems
Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 9898032043212021-08-02
Philips Medical Systems
Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 9898032043112021-08-02
Philips Medical Systems
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 9898032045312021-08-02
Philips Medical Systems
Microstream Advance Pediatric Oral-Nasal CO2 Filter Line 9898032044112021-08-02
Philips Medical Systems
Microstream Advance Pediatric Oral-Nasal CO2 Filter Line 9898032044012021-08-02
Philips Medical Systems
Microstream Advance Pediatric Oral-Nasal CO2 Filter Line 9898032045412021-08-02
Philips Medical Systems
Microstream Advance Neonatal-Infant Nasal CO2 Filter Line 9898032044212021-08-02
Philips Medical Systems
Microstream Advance Adult Oral-Nasal CO2 Filter Line 9898032043812021-08-02
Philips Medical Systems
Microstream Advance Adult Nasal CO2 Filter Line 9898032044812021-08-02
Philips Medical Systems
Microstream Advance Adult-Pediatric CO2 Intubated Filter Line 9898032043312021-08-02
Philips Medical Systems
Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 9898032043012021-08-02
Philips Medical Systems
Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 9898032045212021-08-02
Philips Medical Systems
Microstream Advance Adult-Intermediate Bite Block CO2 Filter Line 9898032044612021-08-02
Philips Medical Systems
Microstream Advance Adult Oral-Nasal CO2 Filter Line 9898032045512021-08-02
Philips Medical Systems
Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph2021-06-30
Philips Medical Systems
HeartStart FRx Defibrillator2021-06-15
Philips Medical Systems
HeartStart FRx Defibrillator2021-06-15
Philips Medical Systems
IntelliBridge 8650562021-06-02
Philips Medical Systems
989803148061 9898031480612021-05-18
Philips Medical Systems
989803148001 9898031480012021-05-18
Philips Medical Systems
989803101571 9898031015712021-05-07
Philips Medical Systems
MX40 Masimo Leadsets and Adapters 9898032024212021-05-07
Philips Medical Systems
MX40 Masimo Leadsets and Adapters 9898032024112021-05-07
Philips Medical Systems
MX40 Masimo Leadsets and Adapters 9898032042912021-03-25
Philips Medical Systems
HeartStart FRx Defibrillator2021-03-10
Philips Medical Systems
HeartStart FRx Defibrillator2021-02-12
Philips Medical Systems
HS Switchless Internal Paddle Adapter 9898031097212021-02-08
Philips Medical Systems
Small Switched Int Pdls 9898031097612020-12-21
Philips Medical Systems
Medium Switched Int Pdls- 9898031097512020-12-21
Philips Medical Systems
Lrg Switched Int Pdls 9898031097412020-12-21
Philips Medical Systems
Extra Lrg Switched Int Pdls 9898031097312020-12-21
Philips Medical Systems
HeartStart FRx Defibrillator2020-12-16
Philips Medical Systems
Holter Software 2020-08-27
Philips Medical Systems
HeartStart FRx Defibrillator2020-08-22
Philips Medical Systems
HeartStart FRx Defibrillator2020-08-03
Philips Medical Systems
HeartStart FRx Defibrillator (861304)2020-07-16
Philips Medical Systems
Avalon Fetal & Maternal Patch 9898031963412020-06-02
Philips Medical Systems
HeartStart FRx Defibrillator2020-05-11
Philips Medical Systems
989805606961 9898056069612020-04-20
Philips Medical Systems
989805606951 9898056069512020-04-20
Philips Medical Systems
Philips Biosensor BX1002020-04-16
Philips Medical Systems
Philips Nasal Alar SpO2 Sensor 9898032054012020-04-13
Philips Medical Systems
PHILIPS NASAL ALAR SPO2 SENSOR 9898032053912020-04-13
Philips Medical Systems
Philips Nasal Alar SpO2 Sensor 9898032053812020-04-13
Philips Medical Systems
989803177881 9898031778812020-04-01
Philips Medical Systems
Philips Wearable Biosensor 9898031968712020-03-05
Philips Medical Systems
Philips Wearable Biosensor 9898031968612020-03-05
Philips Medical Systems
LC Accu-Bar; STRIP, TEMPERATURE, FOREHEAD, LIQUI 9898056230012020-02-24
Philips Medical Systems
Genius 2 9898031796112020-02-06
Philips Medical Systems
Genius 2 9898031793812020-02-06
Philips Medical Systems
Philips 8603432020-02-06
Philips Medical Systems
SureSigns VS4 8633792020-02-06
Philips Medical Systems
SureSigns VS4 8632832020-02-06
Philips Medical Systems
865351 8653512020-02-06
Philips Medical Systems
865350 8653502020-02-06
Philips Medical Systems
Philips Temporal Temperature HH 9898031929312020-02-06
Philips Medical Systems
SureSigns VM8SE 8633172020-02-06
Philips Medical Systems
866212 8662122020-02-06
Philips Medical Systems
865352 8653522020-02-06
Philips Medical Systems
SureSigns VM1 8632642020-02-06
Philips Medical Systems
SureSigns VS4 8632832020-02-06
Philips Medical Systems
SureSigns VS2+ 8632792020-02-06
Philips Medical Systems
SureSigns VS2+ 8632782020-02-06
Philips Medical Systems
SureSigns VSi 8632772020-02-06
Philips Medical Systems
SureSigns VSi 8632762020-02-06
Philips Medical Systems
SureSigns VSi 8632752020-02-06
Philips Medical Systems
865052 8650522020-02-06
Philips Medical Systems
989803171221 9898031712212020-02-06
Philips Medical Systems
865346 8653462020-02-06
Philips Medical Systems
SureSigns VM1 8632662020-02-06
Philips Medical Systems
SureSigns VM1 8632652020-02-06
Philips Medical Systems
SureSigns VM8 8630682020-02-06
Philips Medical Systems
SureSigns VM8 8630662020-02-06
Philips Medical Systems
SureSigns VM6 8630652020-02-06
Philips Medical Systems
SureSigns VM6 8630642020-02-06
Philips Medical Systems
SureSigns VM4 8630632020-02-06
Philips Medical Systems
Rect. Pdl Electrode Repl. M3535A - Gray 9898031433412019-12-17
Philips Medical Systems
989803163251 9898031632512019-12-11
Philips Medical Systems
2019-12-03
Philips Medical Systems
IS Console Critical Care UI B.01 2019-11-21
Philips Medical Systems
Philips 8603222019-11-08
Philips Medical Systems
HOLTER 2019-11-08
Philips Medical Systems
989803179541 9898031795412019-10-23
Philips Medical Systems
IECG 2019-10-22
Philips Medical Systems
2019-10-14
Philips Medical Systems
989803101501 9898031015012019-08-07
Philips Medical Systems
M3290B Patient Information Center IX2019-08-06
Philips Medical Systems
989803150391 9898031503912019-07-22
Philips Medical Systems
MX40 Release C.012018-07-24
Philips Medical Systems
MX40 Release B.072017-11-09
Philips Medical Systems
M3290B Philips IntelliVue Information Center IX2017-07-07
Philips Medical Systems
SureSigns VS3; SureSigns VS42017-03-31
PHILIPS MEDICAL SYSTEMS
CareEvent Inclusive Of The CareEvent Mobile Application Accessory2016-06-24
PHILIPS MEDICAL SYSTEMS
M3290B Philips IntelliVue Information Center IX2016-06-13
PHILIPS MEDICAL SYSTEMS
Philips Efficia CMS200 Central Monitoring System2016-05-05
PHILIPS MEDICAL SYSTEMS
PATIENT MONITORS VARIOUS MODELS2016-01-26
PHILIPS MEDICAL SYSTEMS
Philips CS770 IntelliSpace Critical Care And Anesthesia2015-10-30
PHILIPS MEDICAL SYSTEMS
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra Long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M2015-10-27
PHILIPS MEDICAL SYSTEMS
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING2015-01-23
PHILIPS MEDICAL SYSTEMS
CareEvent2015-01-15
Philips Medical Systems [Philips Medical Systems International BV]
Infant Heel Warmer2009-04-21
Philips Medical Systems [Philips Medical Systems International BV]
Infa-therm Disposable Infant Transport Mattress2009-04-21
Philips Medical Systems [Philips Medical Systems International BV]
Heel Snuggler Infant Heel Warmer2008-04-16
Philips Medical Systems [Philips Medical Systems International BV]
Bilichek2008-04-16
Philips Medical Systems [Philips Medical Systems International BV]
BiliCal2008-04-16

Similar & Related FDA Registered Companies

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092965621Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyMEDICAL SUPPLIES HS:9018191 PKG
2020092861657Stadersand,Federal Republic of Germany -> Savannah, GeorgiaDIGITAL DIAGNOST 4 HIGH PERFORM HS CODE 90221400-76042990 INV90444024 PO451434199710 PCS
2020092549092Shanghai ,China (Mainland) -> Long Beach, CaliforniaDURADIAGNOST REL. 49 PKG
2020092555364Tokyo ,Japan -> Los Angeles, CaliforniaPARTS FOR MEDICAL PARTS SAID TO CONTAIN HS CODE 9018.19,8473.30 TOTAL 13 PACKAGES 7 SK13 PCS
2020092555357Tokyo ,Japan -> Los Angeles, CaliforniaELECTRO-DIANOSTIC APPRATUS FRU,SENSE CAC,3.0T ANTERIOR SAID TO CONTAIN HS CODE9018.19,831 PCS
202009216201Tokyo ,Japan -> Los Angeles, CaliforniaELECTRO-DIANOSTIC APPRATUS PATIENT CONN ASSY SAID TO CONTAIN HS CODE9018.19,8536.70 TOT10 PCS
202009216214Tokyo ,Japan -> Los Angeles, CaliforniaELECTRO-DIANOSTIC APPRATUS SENSE KNEE COIL 8 CHANNEL SAID TO CONTAIN HS CODE9018.19,84713 PCS
2020091966471Tokyo ,Japan -> Los Angeles, CaliforniaELECTRO-DIANOSTIC APPRATUS WIRELESS ECG PATIE NT MODULE GEN 3 1-5 SAID TO CONTAIN HS CODE17 PCS

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